RUFINAMIDE
- Product NDC
- 59651-563
- 11-digit product format
- 596510563
- Labeler code
- 59651
- Product ID
- 59651-563_855369b6-9f5b-4951-9115-dbb9a74ac53b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- RUFINAMIDE
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA216549
- Marketing category
- ANDA
- Marketing start
- 2022-10-26
- Substance
- RUFINAMIDE
- Active strength
- 40 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- RUFINAMIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RUFINAMIDE | 40 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WFW942PR79 |
| Rxcui | 1092357 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-563-60 | RUFINAMIDE | 460 mL in 1 BOTTLE | SUSPENSION | 460 | | 3 |
| 59651-563-60 | RUFINAMIDE | 1 in 1 CARTON | SUSPENSION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-563 | RUFINAMIDE SUSPENSION [AUROBINDO PHARMA LIMITED] | 2 | Current NDC, Legacy NDC, 2 package rows | 20230807_444544f0-7622-4eef-b218-f241bd50d4af.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59651-563-60 | 59651056360 | 1 BOTTLE in 1 CARTON (59651-563-60) / 460 mL in 1 BOTTLE | 1 bottle | 2022-10-26 | 0000-00-00 | No | No | Current |